ScrewIndirect® Implant 403010Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ScrewIndirect Implant (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ScrewIndirect 403010 is a small root-form dental implant used to anchor a replacement tooth in the jawbone. The 50 reports filed since 2020 mostly describe the implant failing to fuse with the surrounding bone, along with difficulty placing it or it ending up in the wrong position; all 50 were injuries and no deaths were reported. Notably, there were 22 reports in the last 12 months and none in the prior12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10841307104711), received between Jan 17, 2020 and Jun 25, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate28
- Difficult to Insert6
- Loss of Osseointegration6
- Positioning Failure6
- Positioning Problem2
- Labelling, Instructions for Use or Training Problem1
- Malposition of Device1
Patient problems
- Failure of Implant27
- No Clinical Signs, Symptoms or Conditions20
- Inadequate Osseointegration16
- Osteopenia/ Osteoporosis11
- No Consequences Or Impact To Patient4
- Pain3
- Inflammation2
- Granuloma1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631358 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628358 ↗InjuryJun 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25487579 ↗InjuryJun 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25402886 ↗InjuryApr 17, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916828 ↗InjuryApr 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24847941 ↗InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24811218 ↗InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24811134 ↗InjuryMar 19, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24644521 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24634948 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24631346 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24630409 ↗InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24585137 ↗InjuryDec 3, 2025Malposition of Device; Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707028 ↗InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23551579 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474496 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462913 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461558 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461557 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461552 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461548 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461547 ↗InjuryAug 15, 2024Positioning Failure; Positioning Failure
COMPL:PRIMARY STABILITY COULDN¿T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 19994565 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19961929 ↗InjuryApr 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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